Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial (ReSET)
The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial|
- daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement [ Time Frame: 3 months follow up ] [ Designated as safety issue: No ]Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.
- ambulatory 24 hours BP measurements [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.
- Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.
- Biomarkers [ Time Frame: 1 months ] [ Designated as safety issue: No ]Biomarkers concerning renal sodium excretion
- Applanation tonometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]Pulse wave velocity, augmentation index, central BP estimates
- forearm plethysmography [ Time Frame: 6 months ] [ Designated as safety issue: No ]Forearm minimum vascular resistance
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Renal artery ablation
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.
Procedure: Renal artery ablation
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
Sham Comparator: Sham
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.
Procedure: Renal angiography
Renal angiography by femoral access.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459900
|Contact: Ole N Mathiassen, MD, PhD||+45 email@example.com|
|Contact: Anne Kaltoft, MD, PhD||+45 firstname.lastname@example.org|
|Aarhus, Aarhus N, Denmark, 8200|
|Contact: Ole N Mathiassen, MD, PhD +45 89495566 email@example.com|
|Principal Investigator: Ole N Mathiassen, MD, PhD|